NCT05020106 · RECRUITING
The Diagnostic Cut-off Value of Core Biomarkers of Alzheimer's Disease
This study is not a treatment trial. Researchers are recruiting people with Alzheimer's disease, mild cognitive impairment, other dementias, and healthy controls to collect blood and cerebrospinal fluid samples. The goal is to find the most reliable cutoff values for biomarkers like amyloid and tau — the biological signals used to diagnose Alzheimer's. Think of it as calibrating the ruler before measuring. No phase is assigned because no drug or intervention is being tested.
You may qualify if
- Aged 55-75. Written informed consent obtained from participant or legal guardian prior to any study-related procedures. The diagnosis of AD is made using the National Institute on Aging and the Alzheimer's Association (NIA-AA) criteria. The diagnosis of aMCI is assigned according to 2004 Petersen criteria. As for non-AD dementia, the McKeith criteria are used for DLB, the revised diagnostic criteria proposed by the International bvFTD Criteria Consortium for behavioral variant FTD, the Gorno-Tempini criteria for the semantic variant FTD or non-fluent aphasia, the Movement Disorder Society Task Force criteria for PDD, the vascular behavioral and cognitive disorders (Vas-Cog) criteria for VaD, the Armstrong's criteria for CBD, the CDC's diagnostic criteria for CJD, etc. In addition, normal cognition is supported by MMSE, CDR and other cognitive function scales.
You're excluded if
- Other medical or psychiatric illness. No one can serve as an informant. Refused to complete a cognitive test and provide biospecimen.
The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.
Eligibility criteria as of 2026-03-23